Diclofenac Sodium
- Product NDC
- 68001-281
- 11-digit product format
- 680010281
- Labeler code
- 68001
- Product ID
- 68001-281_411b49de-cfcc-2b9f-e063-6394a90a06b7
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Diclofenac Sodium
- Dosage form
- TABLET, DELAYED RELEASE
- Route
- ORAL
- Labeler
- BluePoint Laboratories
- Application
- ANDA077863
- Marketing category
- ANDA
- Marketing start
- 2015-12-21
- Substance
- DICLOFENAC SODIUM
- Active strength
- 75 mg/1
- Pharmacologic classes
- Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Diclofenac Sodium
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| DICLOFENAC SODIUM | 75 mg/1 |
Harmonized Identifiers#
| Field | Values |
|---|---|
| Unii | QTG126297Q |
| Rxcui | 855664, 855906, 855926 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 111d457e-3138-4512-b0ba-d0cd760c4055 | Product name | 3 | 20250225 |
| 0426261e-1bb9-b78b-abd2-80da765a7e3e | Product name | 2 | 20240513 |
| 7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7 | Product name | 5 | 20240320 |
| 0ac2f11f-f58d-baf2-71a0-680993b48a61 | Product name | 2 | 20231211 |
| 855d63c3-b090-4636-8fc7-6d39ad23c44f | Product name | 1 | 20230829 |
| bb58f410-04be-65dd-9211-e89ead899698 | Product name | 6 | 20230323 |
| 0fcbc38a-8b29-3348-1cef-5222ea53484f | Product name | 4 | 20220516 |
| c4e1eedc-aca2-4551-8382-89144ed9d049 | Product name | 3 | 20220126 |
| 8d368a34-1453-43ea-828d-0dbcd72b8794 | Product name | 8 | 20210622 |
| d6bab9d2-edce-a213-4796-226ab15472c3 | Product name | 6 | 20200616 |
| 2487e6ef-d419-42fc-aaf8-7acc805d2370 | Product name | 2 | 20170718 |
| e071c814-e5e7-e7ed-ec76-428765d9c66b | Product name | 2 | 20151120 |
| 93148e06-b8d7-4e6c-853e-62f807d17fbb | Product name | 1 | 20151014 |
| dbb00be6-fb1c-4b0a-a770-31f7e05e247e | Product name | 1 | 20150316 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 68001-281-00 | Diclofenac Sodium | 100 in 1 BOTTLE | TABLET, DELAYED RELEASE | 100 | 10 | |
| 68001-281-03 | Diclofenac Sodium | 500 in 1 BOTTLE | TABLET, DELAYED RELEASE | 500 | 10 | |
| 68001-281-06 | Diclofenac Sodium | 60 in 1 BOTTLE, PLASTIC | TABLET, DELAYED RELEASE | 60 | 10 | |
| 68001-281-08 | Diclofenac Sodium | 1000 in 1 BOTTLE | TABLET, DELAYED RELEASE | 1000 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68001-281-00 | EA - Each | 68001-281 | afd98be0-88e3-4b9c-b33a-26a4541cf122 | 1 | 2016-01-13 |
| 68001-281-03 | EA - Each | 68001-281 | 1201c40c-dc30-4f78-8c62-d8150277a95b | 1 | 2016-01-13 |
| 68001-281-06 | EA - Each | 68001-281 | d2be57e1-412f-404d-81e2-a288fcf7b298 | 1 | 2016-01-13 |
| 68001-281-08 | EA - Each | 68001-281 | 0081524d-18c5-4b24-9108-771654caeb7c | 1 | 2016-01-13 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | PSN | feb1541a-de83-47dd-be03-c43376527318 | 10 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | PSN | feb1541a-de83-47dd-be03-c43376527318 | 10 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | feb1541a-de83-47dd-be03-c43376527318 | 10 |
| 855664 | diclofenac sodium 25 MG Delayed Release Oral Tablet | SCD | feb1541a-de83-47dd-be03-c43376527318 | 10 |
| 855906 | diclofenac sodium 50 MG Delayed Release Oral Tablet | SCD | feb1541a-de83-47dd-be03-c43376527318 | 10 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | feb1541a-de83-47dd-be03-c43376527318 | 10 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | dbb1489d-b690-4e53-905d-7fb07ad263b3 | 3 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | dbb1489d-b690-4e53-905d-7fb07ad263b3 | 3 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | f42377a0-9f82-1a1f-e053-2a95a90ae8b5 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | f42377a0-9f82-1a1f-e053-2a95a90ae8b5 | 2 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | PSN | 2ce0741a-7bc7-8aec-e063-6294a90ae9ef | 1 |
| 855926 | diclofenac sodium 75 MG Delayed Release Oral Tablet | SCD | 2ce0741a-7bc7-8aec-e063-6294a90ae9ef | 1 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 68001-281-00 | 68001028100 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-00) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 68001-281-03 | 68001028103 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-03) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 68001-281-06 | 68001028106 | 60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (68001-281-06) | 2015-12-21 | 0000-00-00 | No | No | Current |
| 68001-281-08 | 68001028108 | 1000 TABLET, DELAYED RELEASE in 1 BOTTLE (68001-281-08) | 2015-12-21 | 0000-00-00 | No | No | Current |